Cyclophosphamide and Pulse Dexamethasone With Rapamycin or Hydroxychloroquine

Completed · Early Phase 1

Conditions studied: Myeloma

In brief

The purpose of this study is to determine the feasibility of giving (i) rapamycin or (ii) hydroxychloroquine (HCQ), with standard doses of infusional cyclophosphamide and pulse dexamethasone (cy/dex) for patients with relapsed/refractory multiple myeloma, as well as the feasibility of obtaining multiple blood and bone marrow samples during treatment to assess the pharmacodynamic effects of the treatment.

Key facts

Study ID

NCT01396200

Run by

Abramson Cancer Center at Penn Medicine

People needed

6

Starts

2011-06-01

Expected to finish

2012-10-01

Last updated by the study team

2013-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Each subject must meet ALL of the following criteria during screening to be enrolled:
• Histologically confirmed multiple myeloma
• Documented relapse or persistent disease after at least one prior therapy (which may include autologous and allogeneic bone marrow transplantation)
• Need for further therapy for myeloma, as determined by the patients treating physician
• Age 18 years
• ECOG PS 0-2

You may not qualify if…

• History of allergic reactions to compounds of similar chemical or biological composition to rapamycin or hydroxychloroquine
• Patients may not take any of the following medications while on study (in the rapamycin arms only), but will be considered eligible if medication is discontinued 72 hrs prior to first dose of Rapamycin:
• Carbamazepine (e.g. Tegretol)
• Rifabutin (e.g. Mycobutin)
• Rifampin (e.g. Rifadin)
• Rifapentine (e.g. Priftin)
• St. Johns Wort Clarithromycin (e.g. Biaxin)
• Cyclosporin e.g. (Neorla or Sandimmune)
• Diltiazem (e.g. Cardizem)
• Erythromycin (e.g. Akne-Mycin, Ery-Tab)
• Itraconazole (e.g. Sporonox)
• Fluconazole (e.g. Diflucan)
• Ketoconazole (e.g. Nizoral)
• Telithromycin (e.g. Ketek)
• Verapamil (e.g. Calan SR, Isoptin, Verelan)
• Voriconazole (e.g. VFEND)Tacrolimus (e.g. Prograf)
• Known macular degeneration or retinopathy (diabetic or otherwise), porphyria, or psoriasis (well-controlled psoriasis allowed provided under the care of a specialist who agrees to monitor the patient for exacerbations)
• Patients with the following cytopenias: ANC 1.0 x 109/L; Platelets 50 x 109/L
• Serum Creatinine 2.5 mg/dL; Total or Direct Bilirubin 2.0 mg/dL; Fasting Glucose 200mg/dL
• Other conditions that would require therapy with hydroxychloroquine, including but not limited to, any of the following:
• Systemic lupus
• Rheumatoid arthritis
• Porphyria cutanea tarda
• Malaria treatment or prophylaxis
• Other active malignancy, except:

Where it is running

• Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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